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Study of Valproate in Young Patients Suffering From Epilepsy

NCT00385411 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 81

Last updated 2009-10-06

No results posted yet for this study

Summary

Main objective: Therapeutic follow-up study Evaluate the clinical and biological safety of valproate administered as microgranules, under standard prescription conditions, with therapeutic follow-up and individual dosage adjustment, using valproate plasma concentrations and antiepileptic comedication as well as biological assays.

Secondary objectives: Ancillary population kinetics study

* Estimate the pharmacokinetic parameters of valproate administered as microgranules under standard therapeutic conditions within the population studied, from the therapeutic follow-up data.
* Evaluate the influence of individual characteristics on the pharmacokinetic parameters.
* Describe the relationship between plasma concentrations and adverse events for valproate and the main anti-epileptic comedications.

Conditions

Interventions

DRUG

valproate microgranules

20 to 30 mg/kg/day

Sponsors & Collaborators

Principal Investigators

  • Marie SEBILLE, Dr · Sanofi

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
15 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31
Primary Completion
2008-10-31
Completion
2008-10-31

Countries

  • France

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00385411 on ClinicalTrials.gov